MAUDE Adverse Event Report: ETHICON INC. PROLENE HERNIA SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number	PHSM1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Diarrhea (1811); Memory Loss/Impairment (1958); Pain (1994); Discomfort (2330)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the patient that they underwent an inguinal hernia repair procedure on (b)(6) 2024 and mesh was implanted.Since implantation, the patient has experienced a severe and disabling deterioration of overall health.These symptoms appeared gradually and intermittently after the operation, but they are now chronic.Their intensity varies from day to day and can reach extremely severe episodes that completely prevent me from leaving the house.The patient reports: local and mechanical symptoms: i feel a constant discomfort at the implantation site with a cardboard-like stiffness of the operated area.I have become unable to carry loads or exert any force.Any physical strain triggers shooting pains or a crawling/buzzing sensation that radiates into both of my legs.Neurological and motor symptoms: i suffer from diffuse neuropathic pain throughout my body.My motor abilities in the lower limbs are severely impaired.Cognitively, i experience persistent brain fog, memory losses, and significant concentration difficulties.Diffuse pain and systemic involvement: i have chronic bone pain localized in my legs, pelvis, and arms, as well as diffuse pain elsewhere in my body.My general condition is also marked by digestive disorders (chronic diarrhea) that have caused significant weight loss.All of these symptoms heavily impact my autonomy and daily quality of life, leaving me completely physically incapacitated during the most acute pain episodes.Clinical consequences and current condition: to date, my health is characterized by a chronic and progressive disability.The clinical consequences are: functional impairment: total inability to lift objects, engage in physical activity, or strain the abdominal area without triggering acute pain.Neurological and cognitive impact: persistent brain fog and diffuse neuropathic pain that impair my daily concentration and memory.Deterioration of general condition: physical exhaustion related to bone and systemic pain.Chronic joint and muscle pain make normal daily life impossible, accompanied by weight loss due to chronic digestive disorders.Impact on mobility: motor difficulties in the lower limbs.Current state: my condition is fluctuating but persistent.I experience extremely severe episodes that force me to remain confined at home and prevent any normal social or professional life.The impact on my quality of life is major, with a significant loss of autonomy during painful peaks.I am currently awaiting medical solutions to treat these complications, which i directly attribute to the placement of the mesh.

• Brand Name: PROLENE HERNIA SYSTEM
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): J-PAC; 25 centre rd; somersworth NH 03878
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24913251
• Report Number: 2210968-2026-04147
• Device Sequence Number: 13230095
• Product Code: FTL
• UDI-Device Identifier: 10705031048997
• UDI-Public: (01)10705031048997(17)280831(10)41927J01
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K180829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PHSM1
• Device Lot Number: 41927J01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown